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Dolobid / Diflunisal

 DOLOBID (Diflunisal)
Manufacturer: Merck


 Diflunisal is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), and is primarily used to to reduce pain, inflammation, and stiffness caused by many conditions, such as osteoarthritis, rheumatoid arthritis, and injury.
 

Dolobid a NSAIDS

May cause an increased risk of serious cardiovascular thrombotic events, myocardial

Full Text

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FDA NSAIDs Decision Memo

 

SUBJECT: Analysis and recommendations for Agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk

 

Executive Summary

Following a thorough review of the available data we have reached the following conclusions regarding currently approved COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs)1 and the risk of adverse cardiovascular (CV) events:2


• The three approved COX-2 selective NSAIDs (i.e., celecoxib, rofecoxib, and valdecoxib) are associated with an increased risk of serious adverse CV events compared to placebo. The available data do not permit a rank ordering of these drugs with regard to CV risk.


• Data from large long-term controlled clinical trials that have included a comparison of COX-2 selective and non-selective NSAIDs do not clearly demonstrate that the COX-2 selective agents confer a greater risk of serious adverse CV events than non-selective NSAIDs.

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